TraZODone (Lexi-Drugs)

ALERT: US Boxed Warning
  Suicidal thoughts and behaviors:
Pronunciation

(TRAZ oh done)

Brand Names: US

Oleptro [DSC]

Brand Names: Canada

APO-TraZODone; APO-TraZODone D; DOM-TraZODone; MYLAN-TraZODone [DSC]; NTP-TraZODone [DSC]; Oleptro; PHL-TraZODone HCl [DSC]; PHL-TraZODone [DSC]; PMS-TraZODone; RATIO-TraZODone [DSC]; TEVA-TraZODone; TraZODone-100; TraZODone-150; TraZODone-50

Dosing: Adult

Note: Oleptro, the extended-release formulation, has been discontinued in the United States for more than 1 year.

Aggressive or agitated behavior associated with dementia (alternative agent) (off-label use): Based on limited data: Oral: Immediate release: Initial: 25 to 50 mg once daily at bedtime; may increase dose gradually based on response and tolerability up to 300 mg/day in 1 to 3 divided doses (APA [Rabins 2007]; Lebert 2004; Sultzer 1997). Some experts target doses in the lower end of the dosing range, rarely using doses as high as 100 to 150 mg/day (Press 2018; WFSBP [Ihl 2011]).

Insomnia (alternative agent) (off-label use): Oral: Immediate release: Usual dose: 50 mg to 100 mg at bedtime (Yi 2018). Note: Lower initial doses of 12.5 to 50 mg at bedtime may be considered (eg, in palliative care patients) (McCleery 2014; Tanimukai 2013). May consider increasing dose based on response and tolerability up to 200 mg at bedtime (eg, in patients with substance use disorder) (Friedmann 2008; Le Bon 2003). In patients with substance use disorder, trazodone may be preferred due to its low abuse potential (APA 2006).

Insomnia in patients with depression (as adjunct to other appropriate antidepressant treatment [eg SSRI]): Oral: Immediate release: Usual dose: 50 to 300 mg at bedtime. Doses up to 600 mg/day have been evaluated; however, evidence of greater benefit is uncertain and adverse effects may be increased (Mendelson 2005).

Major depressive disorder (unipolar) (alternative agent): Oral:

Immediate release: Initial: 50 mg twice daily; may increase in increments of 50 mg/day every 3 to 7 days to a target dose of 75 to 150 mg twice daily. Thereafter may further increase by 50 to 100 mg/day every 2 to 4 weeks based on response and tolerability; usual dosage range 200 to 400 mg/day; maximum 600 mg/day. Note: Adverse effects are increased with doses >400 mg/day and are not recommended in patients with cardiovascular disease; sedative effects may be better tolerated by dividing the daily dose to give a smaller dose in daytime and larger dose before bedtime (Hirsch 2018c).

Manufacturer’s labeling: Dosing in prescribing information may not reflect current clinical practice. Initial: 150 mg/day in divided doses; maximum dose: 600 mg/day (inpatients); 400 mg/day (outpatients).

Extended release: Initial: 150 mg once daily at bedtime; may increase by 75 mg/day at intervals no less than every 3 days based on response, tolerability, and severity of symptoms; maximum dose: 375 mg/day

Discontinuation of therapy: When discontinuing antidepressants, gradually taper the dose (eg, over 2 to 4 weeks) to minimize the incidence of withdrawal symptoms and allow for the detection of re-emerging symptoms (APA 2010; WFSBP [Bauer 2015]); antidepressants with a shorter half-life may need to be tapered more slowly (APA 2010) (eg, over 4 weeks [Hirsch 2018a]). If intolerable withdrawal symptoms occur following a dose reduction, resume the previously prescribed dose and/or decrease dose at a more gradual rate (Shelton 2001). Select patients (eg, those with a history of discontinuation syndrome) on long-term treatment (>6 months) may benefit from tapering over >3 months (WFSBP [Bauer 2015]). Evidence supporting ideal taper rates is limited (Shelton 2001; WFSBP [Bauer 2015]).

Switching antidepressants: Evidence for ideal antidepressant switching strategies is limited; strategies include cross-titration (gradually discontinuing the first antidepressant while at the same time gradually increasing the new antidepressant) and direct switch (abruptly discontinuing the first antidepressant and then starting the new antidepressant at an equivalent dose or lower dose and increasing it gradually). Cross-titration (eg, over 1 to 4 weeks depending upon sensitivity to discontinuation symptoms and adverse effects) is standard for most switches, but is contraindicated when switching to or from an MAOI. A direct switch may be an appropriate approach when switching to another agent in the same or similar class (eg, when switching between two SSRIs), when the antidepressant to be discontinued has been used for <1 week, or when the discontinuation is for adverse effects. When choosing the switch strategy, consider the risk of discontinuation symptoms, potential for drug interactions, other antidepressant properties (eg, half-life, adverse effects, and pharmacodynamics), and the degree of symptom control desired (Hirsch 2018b; Ogle 2013; WFSBP [Bauer 2013]).

Switching to or from an MAOI:

Allow 14 days to elapse between discontinuing an MAOI and initiation of trazodone.

Allow 14 days to elapse between discontinuing trazodone and initiation of an MAOI.

Dosing: Geriatric

Major depressive disorder (unipolar) (alternative agent):

Immediate release: Oral: Initial: 25 to 50 mg at bedtime; may increase in increments of 25 to 50 mg/day every 3 days for inpatients and weekly for outpatients, if tolerated; usual dose: 75 to 150 mg/day

Extended release: Refer to adult dosing. Use with caution in the elderly; clinical experience is limited.

Discontinuation of therapy: Refer to adult dosing.

Switching antidepressants: Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling (has not been studied). Use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling (has not been studied). Use with caution.

Dosing: Pediatric

Insomnia; sleep disturbances (in children with comorbid psychiatric disorders): Limited data available; frequently used clinically in children with comorbid psychiatric disorders (eg, mood disorder, anxiety disorder, developmental delay with ADHD) (Owens 2010): Oral: Immediate release formulation:

Children 18 months to 5 years: Dosing based on a subset of a pediatric trial which included young children (n=16; range: 20 months to 5 years) with opsoclonus-myoclonus syndrome and used fixed doses (see below); however, the median overall dose (n=19) reported was 2.6 mg/kg/day (range: 1.2 to 6.9 mg/kg/day) (Pranzatelli 2005)

Children 18 months to <3 years: Initial: 25 mg/dose at bedtime; may increase dose at 2-week intervals in 25 mg increments; maximum dose: 100 mg/dose

Children 3 to 5 years: Initial 50 mg/dose at bedtime; may increase dose at 2-week intervals in 25 mg increments; maximum dose: 150 mg/dose

Children >5 years and Adolescents: Initial: 0.75 to 1 mg/kg/dose or 25 to 50 mg at bedtime; reported range: 0.5 to 2 mg/kg/day (do not to exceed adult dosing: 200 mg/day); reported trials conducted in pediatric patients with comorbid psychiatric disorders (eg, ADHD, autism, developmental delay), or sleep bruxism (Hollway 2011; Kratochvil 2005); when used for palliative care, multiple daily dosing may be necessary; 25 to 50 mg/dose increase gradually to twice or three times daily as needed (do not exceed adult dosing)

Migraine, prophylaxis: Limited data available: Efficacy results variable: Children and Adolescents ≥7 years: Oral: Immediate release formulation: 1 mg/kg/day in 3 divided doses; maximum dose: 150 mg/dose (Battistella 1993; Damen 2005; Lewis 2004)

Discontinuation of therapy: Upon discontinuation of antidepressant therapy, gradually taper the dose to minimize the incidence of withdrawal symptoms and allow for the detection of reemerging symptoms. Evidence supporting ideal taper rates is limited. APA and NICE guidelines suggest tapering therapy over at least several weeks with consideration to the half-life of the antidepressant; antidepressants with a shorter half-life may need to be tapered more conservatively. In addition for long-term treated patients, WFSBP guidelines recommend tapering over 4 to 6 months. If intolerable withdrawal symptoms occur following a dose reduction, consider resuming the previously prescribed dose and/or decrease dose at a more gradual rate (APA 2010; Bauer 2002; Haddad 2001; NCCMH 2010; Schatzberg 2006; Shelton 2001; Warner 2006).

MAO inhibitor recommendations:

Switching to or from an MAO inhibitor intended to treat psychiatric disorders:

Allow 14 days to elapse between discontinuing an MAO inhibitor intended to treat psychiatric disorders and initiation of trazodone.

Allow 14 days to elapse between discontinuing trazodone and initiation of an MAO inhibitor intended to treat psychiatric disorders.

Use with other MAO inhibitors (linezolid or IV methylene blue):

Do not initiate trazodone in patients receiving linezolid or IV methylene blue; consider other interventions for psychiatric condition.

If urgent treatment with linezolid or IV methylene blue is required in a patient already receiving trazodone and potential benefits outweigh potential risks, discontinue trazodone promptly and administer linezolid or IV methylene blue. Monitor for serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or IV methylene blue, whichever comes first. May resume trazodone 24 hours after the last dose of linezolid or IV methylene blue.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). Use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). Use with caution.

Use: Labeled Indications

Major depressive disorder (unipolar): Treatment of unipolar major depressive disorder

Use: Off-Label: Adult

  Aggressive or agitated behavior associated with dementiaLevel of Evidence [C, G]

Data from a limited number of patients studied suggest that trazodone may be beneficial in decreasing symptom frequency and severity, as well as decreasing use of adjunctive medications, in patients with aggression or agitation associated with dementia Ref.

Based on the American Psychiatric Association guidelines for the treatment of Alzheimer disease and other dementias, trazodone may be appropriate for nonpsychotic patients with agitation, particularly those with mild agitation or those who cannot take antipsychotics. Based on the World Federation of Societies of Biological Psychiatry guidelines, trazodone may be appropriate as a last-line option for hyperactive symptoms in dementia (eg, screaming, aggression). Access Full Off-Label Monograph

  InsomniaLevel of Evidence [C]

Data from a meta-analysis of a limited number of controlled trials in patients with and without comorbid conditions (including Alzheimer disease, depression, and opioid dependence) suggest that trazodone may be beneficial in the short-term to decrease number of awakenings and improve sleep quality in patients with insomnia Ref.

The American Academy of Sleep Medicine guidelines for the treatment of chronic insomnia suggest trazodone not be used for sleep-onset or sleep-maintenance insomnia due to insufficient evidence. Access Full Off-Label Monograph

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Dementia:

American Psychiatric Association, “Treatment of Patients with Alzheimer’s Disease and Other Dementias, Second Edition,” October 2007

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the Biological Treatment of Alzheimer’s Disease and Other Dementias,” 2011

Depression:

American Academy of Child and Adolescent Psychiatry, Practice Parameter for the Assessment and Treatment of Children and Adolescents with Depressive Disorders, 2007.

American Psychiatric Association, Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition, May 2010

Canadian Network for Mood and Anxiety Treatments (CANMAT), “Clinical Guidelines for the Management of Major Depressive Disorder in Adults,” October 2009

National Collaborating Centre for Mental Health (NCCMH), “Depression: The NICE Guideline on the Treatment and Management of Depression in Adults (Updated Edition).” 2010.

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 1: Update 2013 on the Acute and Continuation Treatment of Unipolar Depressive Disorders,” 2013.

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 2: Maintenance Treatment of Major Depressive Disorder and Treatment of Chronic Depressive Disorders and Subthreshold Depressions,” 2002.

Administration: Oral

Immediate-release tablet: Administer shortly after a meal or light snack; swallow whole or as a half tablet by breaking along the score line

Extended-release tablet: Take on an empty stomach; swallow whole or as a half tablet without food. Tablet may be broken along the score line, but do not crush or chew.

Administration: Pediatric

Oral: Immediate release: Administer after meals or a snack to decrease lightheadedness, sedation, and postural hypotension

Storage/Stability

Immediate-release tablet: Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF). Protect from light.

Extended-release tablet: Store at room temperature of 15ºC to 30ºC (59ºF to 86ºF). Protect from light.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, constipation, diarrhea, dry mouth, abdominal pain, nausea, vomiting, anxiety, tremors, loss of strength and energy, muscle pain, rhinorrhea, weight gain, or weight loss. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, confusion), signs of low sodium (headache, difficulty focusing, memory impairment, confusion, weakness, seizures, or change in balance), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), irritability, panic attacks, agitation, mood changes, severe headache, edema, tachycardia, abnormal heartbeat, confusion, vision changes, eye pain, eye redness, eye edema, severe dizziness, passing out, priapism, or signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, severe diarrhea) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Desyrel: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf#page=13

Oleptro extended release tablets: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf

Antidepressant medications: http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/ucm100211.pdf

Contraindications

Hypersensitivity to trazodone or any component of the formulation; use of MAOIs intended to treat psychiatric disorders (concurrently or within 14 days of discontinuing either trazodone or the MAOI); initiation of trazodone in a patient receiving linezolid or intravenous methylene blue

Warnings/Precautions

Major psychiatric warnings:

• Suicidal thinking/behavior: [US Boxed Warning]: Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies; consider risk prior to prescribing. Short-term studies did not show an increased risk in patients >24 years of age and showed a decreased risk in patients ≥65 years of age. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors, particularly during the initial 1 to 2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient’s family or caregiver should be instructed to closely observe the patient and communicate condition with health care provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription. Trazodone is not FDA approved for use in pediatric patients.

• The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Worsening depression and severe abrupt suicidality that are not part of the presenting symptoms may require discontinuation or modification of drug therapy. Use caution in high-risk patients during initiation of therapy.

• Prescriptions should be written for the smallest quantity consistent with good patient care. The patient’s family or caregiver should be alerted to monitor patients for the emergence of suicidality and associated behaviors such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania; patients should be instructed to notify their health care provider if any of these symptoms or worsening depression or psychosis occur.

Concerns related to adverse effects:

• Bleeding risk: Drugs that interfere with serotonin reuptake (eg, SSRIs) have been associated with bleeding ranging from relatively minor bruising and epistaxis to life-threatening hemorrhage; similar to these agents, trazodone may also impair platelet aggregation resulting in increased risk of bleeding events, particularly if used concomitantly with aspirin, NSAIDs, warfarin or other anticoagulants.

• Cardiac arrhythmias: Although the risk of conduction abnormalities is low relative to other antidepressants, QT prolongation (with or without torsades de pointes) and ventricular tachycardia have been observed with the use of trazodone (reports limited to immediate-release formulation); use with caution in patients with preexisting cardiac disease (including previous MI, stroke, tachycardia, or conduction abnormalities). Other arrhythmias reported include isolated PVCs, ventricular couplets, and tachycardia with syncope. Concurrent use of CYP3A4 inhibitors may increase the risk of QT prolongation or other cardiac arrhythmia. Not recommended for use in a patient during the acute recovery phase of MI.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Fractures: Bone fractures have been associated with antidepressant treatment. Consider the possibility of a fragility fracture if an antidepressant-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising (Rabenda 2013; Rizzoli 2012).

• Ocular effects: May cause mild pupillary dilation which in susceptible individuals can lead to an episode of narrow-angle glaucoma. Consider evaluating patients who have not had an iridectomy for narrow-angle glaucoma risk factors.

• Orthostatic hypotension/syncope: May cause orthostatic hypotension and syncope (risk is high relative to other antidepressants); use with caution in patients at risk of these effects or in those who would not tolerate transient hypotensive episodes (cerebrovascular disease, cardiovascular disease, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia).

• Priapism: Painful erection >6 hours in duration; rare. Instruct patient to seek medical assistance for erection lasting >4 hours. Use with caution in patients who have conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, leukemia).

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) has occurred with serotonergic agents (eg, SSRIs, SNRIs), particularly when used in combination with other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St John’s wort, tryptophan) or agents that impair metabolism of serotonin (eg, MAO inhibitors intended to treat psychiatric disorders, other MAO inhibitors [ie, linezolid and intravenous methylene blue]). Monitor patients closely for signs of SS such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

• SIADH and hyponatremia: Some antidepressant agents (eg, SSRIs) have been associated with the development of SIADH; hyponatremia has been reported (including severe cases with serum sodium <110 mmol/L), predominately in the elderly. Volume depletion and/or concurrent use of diuretics likely increases risk.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Mania/hypomania: May worsen psychosis in some patients or precipitate a shift to mania or hypomania in patients with bipolar disorder. Monotherapy in patients with bipolar disorder should be avoided. Patients presenting with depressive symptoms should be screened for bipolar disorder. Trazodone is not FDA approved for the treatment of bipolar depression.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizure disorder: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold (Hill 2015).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Discontinuation syndrome: Abrupt discontinuation or interruption of antidepressant therapy has been associated with a discontinuation syndrome. Symptoms arising may vary with antidepressant however commonly include nausea, vomiting, diarrhea, headaches, lightheadedness, dizziness, diminished appetite, sweating, chills, tremors, paresthesias, fatigue, somnolence, and sleep disturbances (eg, vivid dreams, insomnia). Less common symptoms include electric shock-like sensations, cardiac arrhythmias (more common with tricyclic antidepressants), myalgias, parkinsonism, arthralgias, and balance difficulties. Psychological symptoms may also emerge such as agitation, anxiety, akathisia, panic attacks, irritability, aggressiveness, worsening of mood, dysphoria, mood lability, hyperactivity, mania/hypomania, depersonalization, decreased concentration, slowed thinking, confusion, and memory or concentration difficulties. Greater risks for developing a discontinuation syndrome have been associated with antidepressants with shorter half-lives, longer durations of treatment, and abrupt discontinuation. For antidepressants of short or intermediate half-lives, symptoms may emerge within 2 to 5 days after treatment discontinuation and last 7 to 14 days (APA 2010; Fava 2006; Haddad 2001; Shelton 2001; Warner 2006).

• Electroconvulsive therapy: May increase the risks associated with electroconvulsive therapy; consider discontinuing, when possible, prior to ECT treatment.

Geriatric Considerations

Very sedating, but little anticholinergic effects.

Pregnancy Considerations

The ACOG recommends that therapy with antidepressants during pregnancy be individualized; treatment of depression during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary health care provider, and pediatrician. According to the American Psychiatric Association (APA), the risks of medication treatment should be weighed against other treatment options and untreated depression. Consideration should be given to using agents with safety data in pregnancy. For women who discontinue antidepressant medications during pregnancy and who may be at high risk for postpartum depression, the medications can be restarted following delivery. Treatment algorithms have been developed by the ACOG and the APA for the management of depression in women prior to conception and during pregnancy (ACOG 2008; APA 2010; Yonkers 2009).

Pregnant women exposed to antidepressants during pregnancy are encouraged to enroll in the National Pregnancy Registry for Antidepressants (NPRAD). Women 18 to 45 years of age or their health care providers may contact the registry by calling 844-405-6185. Enrollment should be done as early in pregnancy as possible.

Breast-Feeding Considerations

Trazodone is present in breast milk.

The relative infant dose (RID) of trazodone is 2% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 50 mg/day.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000). However, some sources note breastfeeding should only be considered if the RID is <5% for psychotropic agents (Larsen 2015).

The RID of trazodone was calculated using a milk concentration of 100 ng/mL, providing an estimated daily infant dose via breast milk of 0.015 mg/kg/day. This milk concentration was obtained following maternal administration of a single dose of trazodone 50 mg in six otherwise healthy breastfeeding women. The presence of trazodone metabolites was not evaluated. Trazodone concentrations in breast milk peaked about 2 hours following administration, approximately the same time as in the plasma (Verbeeck 1986).

Information related to the use of trazodone in breastfeeding women is limited (Misri 1991; Misri 2006; Verbeeck 1986). Infants of mothers using psychotropic medications should be monitored daily for changes in sleep, feeding patterns, and behavior (Bauer 2013) as well as infant growth and neurodevelopment (Sachs 2013; Sriraman 2015).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. When first initiating an antidepressant in a breastfeeding woman, agents other than trazodone are preferred. Women successfully treated with trazodone during pregnancy may continue use while breastfeeding if there are no other contraindications (Berle 2011).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Central nervous system: Drowsiness (24% to 41%), dizziness (20% to 28%), headache (10% to 20%), nervousness (15%), fatigue (6% to 11%)

Gastrointestinal: Xerostomia (15% to 34%), nausea and vomiting (10% to 13%)

Ophthalmic: Blurred vision (6% to 15%)

1% to 10%:

Cardiovascular: Hypotension (4% to 7%), syncope (3% to 5%), palpitations (<2%), sinus bradycardia (<2%), tachycardia (<2%; may include syncope)

Central nervous system: Confusion (5%), ataxia (2% to 5%), heavy headedness (3%), malaise (3%), lack of concentration (1% to 3%), disorientation (2%), akathisia (<2%), chest pain (<2%), delusions (<2%), hallucination (<2%), hypomania (<2%), memory impairment (<2%), numbness (<2%), paresthesia (<2%), speech disturbance (<2%)

Endocrine & metabolic: Weight loss (6%), weight gain (1% to 5%), change in menstrual flow (<2%), increased libido (<2%)

Gastrointestinal: Constipation (7% to 8%), gastrointestinal disease (6%), diarrhea (5%), flatulence (<2%), increased appetite (<2%), sialorrhea (<2%)

Genitourinary: Early menses (<2%), hematuria (<2%), impotence (<2%), retrograde ejaculation (<2%), urinary frequency (<2%), urinary hesitancy (<2%)

Hematologic & oncologic: Anemia (<2%)

Hypersensitivity: Angioedema (3% to 7%), hypersensitivity reaction (<2%)

Neuromuscular & skeletal: Myalgia (5% to 6%), tremor (3% to 5%), muscle twitching (<2%)

Ophthalmic: Asthenopia (≤3%), eye pruritus (≤3%), eye redness (≤3%)

Respiratory: Nasal congestion (≤6%), paranasal sinus congestion (≤6%), dyspnea (<2%)

Frequency not defined:

Cardiovascular: Hypertension, ventricular premature contractions

Central nervous system: Suicidal ideation, suicidal tendencies

<1%, postmarketing, and/or case reports: Abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, asthenia, atrial fibrillation, bradycardia, breast engorgement, breast hypertrophy, cardiac arrhythmia, cardiac conduction disturbance, cardiac failure, cerebrovascular accident, chills, cholestasis, diplopia, edema, esophageal achalasia, extrapyramidal reaction, female sexual disorder (clitorism), hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, insomnia, jaundice, lactation, leukocytosis, leukonychia, liver enzyme disorder, methemoglobinemia, myocardial infarction, orthostatic hypotension, paranoia, priapism, prolonged QT interval on ECG, pruritus, psoriasis, psychosis, SIADH, skin rash, stupor, tardive dyskinesia, tonic clonic epilepsy, torsades de pointes, urinary incontinence, urinary retention, urticaria, vasodilatation, ventricular ectopy, ventricular tachycardia, vertigo

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Alcohol (Ethyl): May enhance the adverse/toxic effect of TraZODone. Specifically, effects on sleepiness, dizziness, and manual dexterity may be enhanced. Risk C: Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Antipsychotic Agents (Phenothiazines): May enhance the adverse/toxic effect of Serotonin Reuptake Inhibitor/Antagonists. Specifically, this may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Serotonin Reuptake Inhibitor/Antagonists may enhance the hypotensive effect of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Atazanavir: May increase the serum concentration of TraZODone. Management: Consider using a lower dose of trazodone when used in combination with atazanavir. Risk D: Consider therapy modification

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

BusPIRone: May enhance the serotonergic effect of Serotonin Reuptake Inhibitor/Antagonists. Management: The combination of a serotonin reuptake inhibitor,antagonist and buspirone should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Risk D: Consider therapy modification

Clarithromycin: TraZODone may enhance the QTc-prolonging effect of Clarithromycin. Clarithromycin may increase the serum concentration of TraZODone. Management: Consider an alternative to this combination whenever possible. If combined, use a lower trazodone dose and monitor for increased effects of trazodone. Risk D: Consider therapy modification

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Risk X: Avoid combination

Darunavir: May increase the serum concentration of TraZODone. Management: Consider using a lower dose of trazodone when used in combination with darunavir. Risk D: Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Fosamprenavir: May increase the serum concentration of TraZODone. Management: Consider using a lower dose of trazodone when used in combination with fosamprenavir. Risk D: Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fosphenytoin: May decrease the serum concentration of TraZODone. TraZODone may increase the serum concentration of Fosphenytoin. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk – Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Indinavir: May increase the serum concentration of TraZODone. Management: Consider using a lower dose of trazodone when used in combination with indinavir. Risk D: Consider therapy modification

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Linezolid: May enhance the serotonergic effect of TraZODone. This could result in serotonin syndrome. Management: Consider alternatives to this combination whenever possible, and discontinue trazodone prior to administration of linezolid. Waiting at least 2 weeks after trazodone discontinuation to initiate linezolid should minimize the interaction risk. Risk D: Consider therapy modification

Lopinavir: May enhance the QTc-prolonging effect of TraZODone. Lopinavir may increase the serum concentration of TraZODone. Management: Avoid this combination when possible due to the potential for enhanced QT prolongation. If used, consider decreasing the trazodone dose and monitor closely for toxicity. Risk X: Avoid combination

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Methylene Blue: TraZODone may enhance the serotonergic effect of Methylene Blue. This could result in serotonin syndrome. Risk X: Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Risk C: Monitor therapy

Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Risk C: Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Serotonin Reuptake Inhibitor/Antagonists. While methylene blue and linezolid are expected to interact, specific recommendations for their use differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Exceptions: Linezolid; Methylene Blue; Tedizolid. Risk X: Avoid combination

Nelfinavir: May increase the serum concentration of TraZODone. Management: Consider using a lower dose of trazodone when used in combination with nelfinavir. Risk D: Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Opioid Agonists: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Phenytoin: May decrease the serum concentration of TraZODone. TraZODone may increase the serum concentration of Phenytoin. Risk C: Monitor therapy

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk – Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Ritonavir: May increase the serum concentration of TraZODone. Management: Consider using a lower dose of trazodone when used in combination with ritonavir. Risk D: Consider therapy modification

Saquinavir: May enhance the QTc-prolonging effect of TraZODone. Saquinavir may increase the serum concentration of TraZODone. Risk X: Avoid combination

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the serotonergic effect of Serotonin Reuptake Inhibitor/Antagonists. This may cause serotonin syndrome. Management: Consider alternatives, and use conservative initial dosing. Monitor patients receiving these combinations for signs/symptoms of serotonin toxicity. Risk D: Consider therapy modification

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid.Risk C: Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

St John’s Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Risk D: Consider therapy modification

Tedizolid: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Tipranavir: May increase the serum concentration of TraZODone. Management: Consider using a lower dose of trazodone when used in combination with tipranavir. Risk D: Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Venlafaxine: May enhance the serotonergic effect of TraZODone. This could result in serotonin syndrome. Risk D: Consider therapy modification

Warfarin: TraZODone may diminish the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Food Interactions

Time to peak serum levels may be increased if immediate release trazodone is taken with food. Management: Administer immediate release after a meal or light snack. Administer extended release on an empty stomach.

Test Interactions

May interfere with urine detection of amphetamine/methamphetamine (false-positive) (Brahm 2010).

Monitoring Parameters

Baseline liver function prior to and periodically during therapy; suicide ideation (especially at the beginning of therapy or when doses are increased or decreased); signs/symptoms of serotonin syndrome; signs/symptoms of hypotension or orthostasis

Advanced Practitioners Physical Assessment/Monitoring

Initiate at lower doses and taper dosage slowly when discontinuing.

Nursing Physical Assessment/Monitoring

Monitor therapeutic response (eg, mental status, mood, affect, suicide ideation) at beginning of therapy and periodically throughout.

Product Availability

Oleptro has been discontinued in the United States for more than 1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as hydrochloride:

Generic: 50 mg, 100 mg, 150 mg, 300 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride:

Oleptro: 150 mg [DSC], 300 mg [DSC]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 75 mg

Tablet, Oral, as hydrochloride:

Generic: 50 mg, 100 mg, 150 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride:

Oleptro: 150 mg, 300 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • N06AX05
Generic Available (US)

May be product dependent

Pricing: US

Tablets (traZODone HCl Oral)

50 mg (per each): $0.44 – $1.07

100 mg (per each): $0.73 – $1.39

150 mg (per each): $1.47 – $2.79

300 mg (per each): $5.44

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Inhibits reuptake of serotonin, causes adrenoreceptor subsensitivity, acts as a 5HT2a receptor antagonist and induces significant changes in 5-HT presynaptic receptor adrenoreceptors. Trazodone also significantly blocks histamine (H1) and alpha1-adrenergic receptors.

Pharmacodynamics/Kinetics

Onset of action: Therapeutic (antidepressant): Up to 6 weeks (APA 2010).

Absorption: Well absorbed. Food increases absorption, decreases peak concentration and delays time to peak concentration of immediate release tablet; Extended release: Cmaxincreases ~86% when taken shortly after ingestion of a high-fat meal compared to fasting conditions

Protein binding: 89% to 95%

Metabolism: Hepatic via CYP3A4 (extensive) to an active metabolite (mCPP)

Bioavailability: 100% (Hiemke 2018)

Half-life elimination: 5 to 9 hours, prolonged in obese patients

Time to peak, serum:

Immediate release: 30 to 100 minutes; delayed with food (up to 2.5 hours)

Extended release: 9 hours; not significantly affected by food

Excretion: Primarily urine (74%, <1% excreted unchanged); secondarily feces (~21%)

Local Anesthetic/Vasoconstrictor Precautions

Trazodone inhibits reuptake of both serotonin and norepinephrine and also blocks some serotonin receptors. No precautions with vasoconstrictors appear to be necessary.

Trazodone is one of the drugs confirmed to prolong the QT interval and is accepted as having a risk of causing torsade de pointes. The risk of drug-induced torsade de pointes is extremely low when a single QT interval prolonging drug is prescribed. In terms of epinephrine, it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval. Until more information is obtained, it is suggested that the clinician consult with the physician prior to the use of a vasoconstrictor in suspected patients, and that the vasoconstrictor (epinephrine, mepivacaine and levonordefrin [Carbocaine® 2% with Neo-Cobefrin®]) be used with caution.

Dental Health Professional Considerations

See Local Anesthetic/Vasoconstrictor Precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Significant xerostomia (normal salivary flow resumes upon discontinuation).

Effects on Bleeding

No information available to require special precautions

Index Terms

Desyrel; Trazodone Hydrochloride

FDA Approval Date
December 24, 1981
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Brand Names: International

Azonz (FI); Deprax (ES); Deprel (PK); Depresil (PH); Desirel (TH); Desyrel (JP); Devidon (HR); Donaren (BR); Donaren Retard (BR); Mesyrel (TW); Molipaxin (GB, IE); Nestrolan (BE); Oleptro (BM); Pragmarel (FR); Reslin (JP); Taxagon (AR); Taxagon AC (UY); Tazodac (IN); Thombran (DE); Trazo (TH); Trazodil (IL); Trazodone-Continental (LU); Trazolan (BE, IN, LU); Trazone (PT, TW); Trazonil (IN); Trittico (AE, AT, BG, BH, CH, CL, CO, CY, EG, GR, HK, HN, IL, IQ, IR, IT, JO, KR, KW, LB, LY, OM, PE, PL, PY, QA, RU, SA, SG, SI, SK, SY, UA, VE, YE); Trittico AC (CL, CO, CZ, RO); Trittico CR (KR); Trittico Prolonged-Release (HK); Zodonrel (TH)

Trazodone (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(TRAZ oh done)

Brand Names: US

Oleptro [DSC]

Brand Names: Canada

Oleptro; Trazorel

Warning
  • For all patients taking this drug:
  • Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
  • Children:
  • This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
What is this drug used for?
  • It is used to treat low mood (depression).
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to trazodone or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have had a recent heart attack.
  • If you have ever had a long QT on ECG or other heartbeat that is not normal.
  • If you have any of these health problems: Low magnesium levels, low potassium levels, or slow heartbeat.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • An unsafe heartbeat that is not normal (long QT on ECG) has happened with this drug. This may raise the chance of sudden death. Talk with the doctor.
  • This drug may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
  • Some people may have a higher chance of eye problems with this drug. Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
  • This drug can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death. Talk with the doctor.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Extended-release tablets:
  • Do not give to a child. Talk with your doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Swelling.
  • Feeling confused.
  • Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Feeling sleepy.
  • Constipation.
  • Dry mouth.
  • Diarrhea.
  • Stomach pain.
  • Headache.
  • Upset stomach or throwing up.
  • Feeling nervous and excitable.
  • Shakiness.
  • Feeling tired or weak.
  • Muscle pain.
  • Stuffy nose.
  • Weight gain or loss.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • If you feel sleepy after taking this drug, talk with your doctor. Your doctor may change your dose or when you take this drug.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • It may take several weeks to see the full effects.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Short-acting products:
  • Take this drug right after a meal or light snack.
  • Tablet may be broken in half.
  • Do not chew or crush.
  • Extended-release tablets:
  • Take on an empty stomach.
  • Swallow whole. Do not chew or crush.
  • Long-acting tablets may be broken in half.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Trazodone (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(TRAZ oh done)

Brand Names: US

Oleptro [DSC]

Brand Names: Canada

Oleptro; Trazorel

Warning
  • Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
  • This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
What is this drug used for?
  • It is used to treat low mood (depression).
  • It may be given to your child for other reasons. Talk with the doctor.
  • Extended-release tablets:
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has had a recent heart attack.
  • If your child has ever had a long QT on ECG or other heartbeat that is not normal.
  • If your child has any of these health problems: Low potassium levels, low magnesium levels, or slow heartbeat.
  • If your child is taking any of these drugs: Linezolid or methylene blue.
  • If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If your child is taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • An unsafe heartbeat that is not normal (long QT on ECG) has happened with this drug. This may raise the chance of sudden death. Talk with the doctor.
  • This drug may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
  • Some people may have a higher chance of eye problems with this drug. The doctor may want your child to have an eye exam to see if your child has a higher chance of these eye problems. Call the doctor right away if your child has eye pain, change in eyesight, or swelling or redness in or around the eye.
  • This drug can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death. Talk with the doctor.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Swelling.
  • Feeling confused.
  • Call your child’s doctor right away if your child gets a painful erection (hard penis) or gets an erection that lasts for longer than 4 hours. If this is not treated right away, it may lead to lasting sex problems and your child may not be able to have sex in the future.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call your child’s doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; a fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dizziness.
  • Feeling sleepy.
  • Constipation.
  • Dry mouth.
  • Diarrhea.
  • Stomach pain.
  • Headache.
  • Upset stomach or throwing up.
  • Feeling nervous and excitable.
  • Shakiness.
  • Feeling tired or weak.
  • Muscle pain.
  • Stuffy nose.
  • Weight gain or loss.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug right after a meal or light snack.
  • Tablet may be broken in half.
  • Do not let your child chew or crush.
  • If your child feels sleepy after taking this drug, talk with your child’s doctor. Your child’s doctor may change your child’s dose or when you give this drug.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • It may take several weeks to see the full effects.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of seizures. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.